J&J’s Ekdahl Says Hips Recalled Because of Clinical Needs

By Maurice Possley, David Voreacos and Jef Feeley -
Jan 31, 2013

Andrew Ekdahl, the president of
Johnson & Johnson (JNJ)’s DePuy unit, told jurors the company recalled
93,000 all-metal hip implants because they “did not meet the
clinical needs for the product” and not because they were
unsafe.

Ekdahl testified yesterday by videotape at the first of
10,000 cases to go to trial over patient claims that J&J
defectively designed the implants and failed to warn of the
risks before the recall of the ASR devices in August 2010. At
the time, J&J said that 12 percent of the devices failed in the
U.K. Analysts estimate the lawsuits could cost J&J billions of
dollars.

Ekdahl, who became DePuy president in January 2012, had
previously worked as a marketing executive. A lawyer for Loren
Kransky, 65, a Montana man who is suing DePuy over his failed
hip, repeatedly questioned Ekdahl about whether the company
withdrew the hips because they were unsafe.

“It was taken off the market because it did not meet the
clinical needs for the product in the marketplace,” Ekdahl said
in a videotaped deposition taken in December 2012 and shown
yesterday to state court jurors in Los Angeles.

J&J, the world’s largest seller of health-care products,
denies that it defectively designed the device or that it
contributed to Kransky’s health problems. J&J is based in New
Brunswick, New Jersey.

Kransky attorney Michael Kelly asked Ekdahl a half-dozen
ways whether DePuy considered ASR hips to be unsafe or harmful
to patients. Each time, Ekdahl referred to clinical needs.

Acceptable Rate

Kelly has told jurors that an internal DePuy analysis in
September 2011 showed 37 percent of ASR hips failed within 4.5
years, and that Australian national registry data showed in 2012
that 44 percent failed after seven years. Patients with failed
hips need replacement surgery known as a revision.

In answering Kelly’s questions about the recall, Ekdahl
said that the ASR didn’t have an acceptable revision rate.

“What was the acceptable revision rate?” Kelly asked.

“I don’t think we put a revision rate on paper and said
this is a revision rate that was acceptable,” Ekdahl said in a
deposition that may be played in many other lawsuits.

Kelly asked how many revisions DePuy forecasts for the U.S.

“We’re not forecasting a revision rate,” Ekdahl said.

Kelly asked why the U.S. rate of revision wouldn’t reach 40
percent, as in Australia. Ekdahl said he doesn’t know what the
rate will be. About 32,000 patients had ASR devices implanted in
the U.S., said Ekdahl, who said that “somewhere in the
neighborhood of 15 to 20 percent” of those hips had failed.

Surgeon Complaints

Kelly questioned Ekdahl about DePuy’s handling of safety
complaints that surgeons filed with the company about the
device. Thousands of lawsuits claim the ASR device left them in
pain or immobilized by joint dislocations, infections and bone
fractures. Many also claim the devices shed chromium and cobalt
into the bloodstream, raising those metals to harmful levels.

One surgeon, William Griffin, e-mailed Ekdahl and others on
Dec. 18, 2008, to say he had “concerns about the design and
have started to see failures consistent with my concerns.”
Surgeons implanted a metal cup in the hip and a metal ball atop
the femur that rotated inside the cup. Griffin said the ASR
didn’t stimulate enough bony ingrowth, the cup was too small,
and the design created sharp edges.

“DePuy should at least de-emphasize the ASR cup while the
clinical results are studied,” Griffin wrote. “I do not use
the ASR. The ASR is not the only bad design out there but it
certainly is not as good as some of the others.”

Clinical Team

Kelly asked if the e-mail went to DePuy’s clinical team.

“I believe this was reported to our clinical team,”
Ekdahl said. “I just don’t recall who did it. We should have
done it. I’m assuming that we did it. I don’t recall.”

Kelly asked about DePuy discussions in 2008 to redesign the
ASR cup. A company engineer, Graham Isaac, e-mailed Ekdahl on
April 30, 2008, to say the ASR is “susceptible to extreme metal
ion levels,” which a competitor product didn’t face.

“We need to discuss that at the earliest possible
opportunity as I believe it means that we need to start any ASR
upgrade sooner than our previous plans had suggested,” Isaac
wrote.

Ekdahl said that in response to the e-mail, he spoke to
people on the marketing team.

Throughout the videotape yesterday, Kelly pursued various
lines of questioning based on DePuy e-mails and internal
documents that he contends show that company officials knew
years before the 2010 recall that the ASR was failing.

‘Project Alpha’

Kelly showed documents related to DePuy’s deliberations in
2008 to redesign the ASR cup through “Project Alpha.” That
project was never completed.

He asked Ekdahl about minutes of a May 2008 meeting in Las
Vegas. Those minutes listed weaknesses of the ASR, including
deformation and loosening of the cup.

At a September 2009 meeting of the company’s U.S. board
overseeing joint devices, officials said the revision rate of
the ASR XL device was two or three times that of another DePuy
implant, the Pinnacle. It said that the impending publication of
Australian registry data would be “very damaging to the ASR.”

To contact the reporters on this story:
Maurice Possley in Los Angeles Superior Court
at mauricepossley@gmail.com;
David Voreacos in Newark, New Jersey, at
dvoreacos@bloomberg.net;
Jef Feeley in Wilmington, Delaware, at
jfeeley@bloomberg.net